WO2021024485A1 - ハラル対応除菌液 - Google Patents
ハラル対応除菌液 Download PDFInfo
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- WO2021024485A1 WO2021024485A1 PCT/JP2019/031501 JP2019031501W WO2021024485A1 WO 2021024485 A1 WO2021024485 A1 WO 2021024485A1 JP 2019031501 W JP2019031501 W JP 2019031501W WO 2021024485 A1 WO2021024485 A1 WO 2021024485A1
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01P—BIOCIDAL, PEST REPELLANT, PEST ATTRACTANT OR PLANT GROWTH REGULATORY ACTIVITY OF CHEMICAL COMPOUNDS OR PREPARATIONS
- A01P1/00—Disinfectants; Antimicrobial compounds or mixtures thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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- C—CHEMISTRY; METALLURGY
- C01—INORGANIC CHEMISTRY
- C01B—NON-METALLIC ELEMENTS; COMPOUNDS THEREOF; METALLOIDS OR COMPOUNDS THEREOF NOT COVERED BY SUBCLASS C01C
- C01B11/00—Oxides or oxyacids of halogens; Salts thereof
- C01B11/08—Chlorous acid
Definitions
- the present disclosure relates to a sterilizing solution containing chlorinated water, which sterilizes the animal by directly contacting the sterilizing solution with the animal.
- Halal-compatible products have not been confirmed at this time.
- the present invention provides the following items.
- (Item 1) A sterilizing solution containing chlorite water, which sterilizes the animal by directly contacting the sterilizing solution with the animal.
- (Item 2) The disinfectant solution according to item 1, wherein the contact is achieved by a rubbing method, a scrub method or a basin method.
- (Item 3) The sterilizing solution according to item 2, wherein the phosphate buffer solution contains two or more kinds of phosphates.
- the phosphate buffer solution contains two or more of potassium dihydrogen phosphate, dipotassium hydrogen phosphate, and sodium dihydrogen phosphate.
- (Item 5) The sterilizing solution according to item 4, wherein the potassium dihydrogen phosphate is 0.68% to 13.61%, and the sodium dihydrogen phosphate is 0.60% to 12.00%.
- (Item 6) The disinfectant solution according to item 4, wherein the potassium dihydrogen phosphate is 1% and the sodium dihydrogen phosphate is 1%.
- (Item 7) The sterilizing solution according to item 4, wherein the potassium dihydrogen phosphate is 0.68% to 13.61%, and the dipotassium hydrogen phosphate is 0.87% to 17.42%.
- (Item 8) The disinfectant solution according to item 4, wherein the potassium dihydrogen phosphate is 1% and the dipotassium hydrogen phosphate is 1%.
- (Item 9) The sterilizing solution according to any one of items 1 to 8, wherein the animal is a living animal.
- the disinfectant solution according to item 10 wherein the surface of the animal is skin.
- (Item 14) The sterilizing solution according to any one of items 1 to 13, wherein the sterilization is performed in the preparation of food.
- (Item 15) The disinfectant solution according to any one of items 1 to 14, wherein chlorous acid is used at 10 ppm to 60,000 ppm.
- (Item 16) The disinfectant solution according to any one of items 1 to 15, wherein chlorous acid is used at 200 ppm to 8,000 ppm.
- (Item 17) The sterilizing solution according to any one of items 1 to 16, wherein the free chlorine concentration of the chlorinated water is 0.25 mg / L to 1,500 mg / L.
- (Item 18) The sterilizing solution according to any one of items 1 to 17, wherein the sterilization targets at least one selected from viruses, bacteria, and eukaryotes.
- the sterilizing solution according to any one of items 1 to 18, wherein the sterilizing solution does not contain an animal-derived component, an alcohol component, or a fragrance.
- a halal-compatible hand sanitizer containing 1.00% chlorous acid water, 1.00% sodium dihydrogen phosphate, 1.00% potassium dihydrogen phosphate, and 97.00% ion-exchanged water.
- a disinfectant solution having 400 ppm of chlorous acid and 10 mg / L of free chlorine concentration.
- a halal-compatible hand sanitizer containing 20.00% chlorous acid water, 1.00% potassium dihydrogen phosphate, 1.00% dipotassium hydrogen phosphate, and 78.00% ion-exchanged water.
- a disinfectant solution having 8,000 ppm of chlorous acid and 200 mg / L of free chlorine concentration.
- Sodium hypochlorite which is used in the field of disinfectants, is strongly irritating to the skin such as rough hands when directly sprayed or immersed in the disinfectant site, and direct use is not preferable.
- Sodium hypochlorite is prescribed in the drug approval as an effective chlorine concentration of 0.01 to 0.05% (100 ppm to 500 ppm), but this concentration is the minimum concentration that causes cytotoxicity. It is higher than 0.001% (10 ppm; Japanese Journal of Infectious Diseases Vol.71 (2016), No.5 pp.333-337), and its use as a drug is limited to very limited cases, but the present disclosure It was found that the chlorite water in the water does not have such restrictions.
- Povidone iodine preparations used in the field of disinfectants are not recommended for iodine hypersensitivity or problems with thyroid function, and are irritating to the skin, coloring (browning), and surgical incisions.
- the chlorinated waters of the present disclosure have been found to have no such restrictions.
- Alcohols used in the field of disinfectants are also irritating to the skin, but the chlorinated water of the present disclosure has been found to be extremely less irritating.
- alcohols are dangerous substances (class 4 alcohols), so there are restrictions on the storage and installation locations and, in some cases, the quantity.
- the chlorinated water of the present disclosure is norovirus.
- Benzalkonium chloride used in the field of disinfectants is a low-level disinfectant, effective against general bacteria and yeast-like fungi, and has a narrow antibacterial spectrum.
- the benzoic acid water of the present disclosure has been found to have a disinfecting effect on a broad antibacterial spectrum.
- the present application provides a sterilizing solution capable of sterilizing an animal by directly contacting the animal.
- the sterilizing solution containing chlorinated water can come into direct contact with animals, disinfection with a high sterilizing effect such as rubbing method (rubbing method), scrub method (cleaning method), and basin method (immersion method). It can be sterilized firmly using the method. All four disinfection methods (rubbing method, scrub method, swab method, basin method) can be used for the chlorinated water and chlorinated water preparations of the present disclosure.
- chlorite water and chlorite water preparation correspond to high-level disinfectants that can also sterilize and disinfect spores, and can be used for each disinfection method, so there is the advantage that one drug can be used for batch management. There is also.
- the disinfectant solution containing chlorite water can be an alcohol-free and animal-free fragrance-free disinfectant, it can also be used in the production of halal foods.
- FIG. 1 shows the skin of the test substance treatment group of Example 2.
- FIG. 2 shows the skin of the comparative control substance treatment group of Example 2.
- FIG. 3 shows the ocular reaction of Example 3.
- FIG. 4 shows a treatment site treated with the test substance of Example 4.
- FIG. 5 shows the treatment site treated with the negative control group of Example 4.
- FIG. 6 shows the treatment site treated with the negative control group of Example 4.
- FIG. 7 shows the treatment site treated with the positive control group of Example 4.
- references to "about” with respect to values or parameters herein include variability with respect to the values or parameters themselves. Unless otherwise specified, for example, “about X” includes “X” itself and a value that allows an error of ⁇ 10% thereof.
- chlorous acid water is an aqueous solution containing chlorous acid (HClO 2 ) used as a bactericidal agent, which creates a stable chemical equilibrium state and transfers chlorous acid to chlorine dioxide. By delaying the decomposition reaction, chlorous acid (HClO 2 ) can be stably maintained for a long period of time.
- acid chlorite ion represent the peak around 260nm between wavelengths 240 ⁇ 420 nm in the UV spectrum (H + + ClO 2 -) in the absorbing section and 350nm near containing
- the presence of chlorinated water can be recognized when two absorption portions containing chlorine dioxide (ClO 2 ) representing a peak can be confirmed at the same time, that is, when a twin aneurysm is indicated.
- Mainly chlorite (HClO 2) At this time, chlorine dioxide (ClO 2), and acidic chlorite ion (H + + ClO 2 -) considered cycle reaction is proceeding concurrently.
- the chlorinated water can be prepared by the method disclosed in International Publications WO2008 / 026607, WO2014 / 188310, WO2014 / 188311, WO2014 / 188312, WO2015 / 093062, and WO2017 / 170904.
- Chlorous acid water was designated as a food additive on February 1, 2013, and is a bactericidal agent containing chlorous acid (HClO 2 ) as the main active ingredient, and is the main ingredient of this "chlorous acid water".
- the active ingredient, chlorous acid (HClO 2 ) is a semi-stable chemical and is recognized by the US USDA and FDA as a particularly safe substance in food additives: processing aids.
- chlorinated water can exert a strong bactericidal effect even in the presence of organic substances, and the National Institute of Health Sciences (commonly known as the National Institute of Health Sciences) stated that “2015 norovirus inactivation”.
- the National Institute of Health Sciences commonly known as the National Institute of Health Sciences
- “2015 norovirus inactivation” In the “Survey on Conditions”, it was highly evaluated that “only chlorinated water could be inactivated below the detection limit under all load conditions", and "mass cooking facility cooking manual” " In order of large-scale food poisoning accidents such as "Pickle Sanitation Standards", chlorinated water is being listed along with the revision of the Food Sanitation Law Enforcement Regulations.
- Chlorous acid water whose main active ingredient is chlorous acid, has a strong bactericidal activity equal to or higher than that of "hypochlorite water” and "sodium hypochlorite". Its reactivity is gradual, and although it does not have a bactericidal effect (immediate effect) that is exerted instantly, it possesses gradual reactivity while having accurate bactericidal activity, and also maintains stable bactericidal activity.
- "Chlorous acid water” has the feature that it is slow but surely in a dirty environment where a lot of organic substances are present, which has been said to be the weakest point for chlorine oxide chemicals so far. Moreover, the bactericidal effect can be accurately exhibited. (Bactericidal power against microorganisms lurking in dirt).
- resistant bacteria that have been difficult to sterilize until now (heat-resistant bacteria whose resistance increases by forming spores, drug-resistant bacteria for which antibiotics are no longer effective, etc.), fungi such as mold and yeast, Furthermore, it can exert an inactivating effect on viruses (including non-enveloped viruses).
- "Hydronic acid water” does not need to be adjusted at the time of use, does not require a dedicated generator for that purpose, and can be used by anyone when they want to use it anywhere, and it is safe.
- sterilization means removing microorganisms such as filamentous fungi, bacteria, and viruses having pathogenicity, harmfulness, and infectivity.
- the specification uses a broad concept including not only eradication (action) but also antibacterial (action), sterilization (action), and disinfection (action). Therefore, those having an antibacterial action, a bactericidal action, a sterilizing action, and a disinfecting action are collectively referred to as a "sterilizing agent" in the present specification, and when used normally in the present specification, the antibacterial action or the sterilizing action, It is understood to be a drug that also has contents corresponding to bactericidal action, sterilizing action, and disinfecting action.
- microorganisms eradicated in the present specification include microorganisms that cause food poisoning, pathogenic microorganisms, microorganisms that may cause infectious diseases, drug-resistant microorganisms (bacteria), and the like. Fecal Escherichia coli, pathogenic Escherichia coli, Staphylococcus aureus, Salmonella spp., Vibrio parahaemolyticus, Campylobacter, Clostridium perfringens, and Bacillus cereus. The relationship between the microorganisms that cause food poisoning, pathogenic microorganisms, microorganisms that may cause infectious diseases, and drug-resistant bacteria (bacteria) is as follows.
- infectious disease means that the host is infected from humans, animals, the environment, etc., the amount of pathogens becomes constant in the body, and symptoms such as fever, diarrhea, and cough appear in the host. It can occur even with a small amount of microorganisms.
- virus the infected host may continue to coexist with the virus for a long period of time and become a carrier (persistent infection), or an infection that does not lead to disease (subclinical infection).
- Infection means that a pathogen invades the body of a host (human or animal) and grows and proliferates in the body.
- pathogen refers to a microorganism (bacteria, virus, fungus, liquettia, protozoan, parasite) that infects and causes a disease, and a pathogen excluding the parasite is called a "pathogenic microorganism”.
- Class 1 infectious diseases (Ebola hemorrhagic fever, Chlamydia congo fever, hemorrhoids, South American hemorrhagic fever, pest, Marbrook's disease, Lassa fever, etc.), Class 2 infectious diseases (acute gray-white scab (porio), tuberculosis, diphtheria, SARS, etc.), Class 3 infectious diseases (cholera, bacterial dysfunction, intestinal hemorrhagic Escherichia coli infection, intestinal typhoid, paratyphus, etc.), class 4 infectious diseases (hepatitis A / E, malaria, yellow fever, Q fever, mad dog disease, botulinum disease, malaria, etc. ), Type 5 infectious diseases (influenza, viral hepatitis, crosspolydium disease, AIDS, regular chlamydia infections, syphilis, hepatitis, MRSA, norovirus, etc.).
- food poisoning refers to oral infection caused by eating or drinking (orally ingested) food (case). Food poisoning is a food-borne infection and is part of the infection. Many food poisoning incidents occur every year by ingesting meat, etc., caused by animals (livestock) and microorganisms existing in the natural world. Bacterial food poisoning includes infectious infectious type (Salmonella, etc.), infectious toxin type (Vibrio parahaemolyticus, pathogenic Escherichia coli, etc.), and toxin type such as Staphylococcus aureus and Clostridium botulinum.
- Viral food poisoning includes those caused by norovirus, hepatitis A virus, hepatitis E virus and the like.
- Chemical food poisoning includes those caused by harmful food additives (arsenic, residual pesticides, etc.), pollutants, and the like.
- Natural food poisoning includes animal-derived substances such as puffer fish poison and shellfish poisoning, which are natural poisons, and plant-derived substances such as poisonous mushrooms and poisonous plants, which are natural poisons. Allergic food poisoning is also mentioned.
- the "pathogenic microorganism” refers to a microorganism that is transmitted through humans and the environment, excluding food poisoning (oral infection). Infected individuals can spread the microorganisms through diarrhea, vomiting, coughing, etc. and become infected by secondary infection.
- drug resistance refers to a phenomenon in which drugs having some action on oneself, such as antibiotics, have resistance, and these drugs do not work or become difficult to work. It occurs when an animal (human) becomes infectious and becomes resistant to the drug (antibiotic) in the body when treated with antibiotics. All bacteria may have acquired resistance to some antibiotics. Antibiotics include bacteriostatic agents (which suppress the growth of bacteria) and fungicides (which kill bacteria).
- drug-resistant bacteria means bacteria that have acquired drug resistance.
- drug-resistant bacteria include methicillin-resistant yellow staphylococcus (MRSA), multidrug-resistant green pus (MDRP), vancomycin-resistant enterococci (VRE), Clostridium difficile (CD: spore formation, toxin production), and vancomycin.
- MRSA methicillin-resistant yellow staphylococcus
- MDRP multidrug-resistant green pus
- VRE vancomycin-resistant enterococci
- CD Clostridium difficile
- vancomycin examples include, but are not limited to, resistant yellow staphylococci, multidrug-resistant yellow staphylococcus, green pustulosis, penicillin-resistant pneumoniae bacilli, multidrug-resistant acinetobacter, carbapenem-based antibacterial agent-resistant bacteria, and multidrug-resistant seratia.
- drug resistance genes are generally acquired as genes that confer drug resistance.
- the present invention is considered to have a bacterial killing effect by destroying such a gene or a gene product as well. Therefore, the present invention has been demonstrated to be effective for specific multidrug-resistant bacteria that can tolerate a plurality of drugs, and those skilled in the art can be extrapolated to those that are generally effective for simpler drug-resistant bacteria. Understood by.
- multidrug-resistant bacteria refers to bacteria that have acquired drug resistance against a plurality of drugs (particularly antibiotics).
- the "sterilizing solution” means a liquid disinfectant.
- contacting the disinfectant solution directly with the animal means contacting the animal by spraying the disinfectant solution or immersing the disinfectant portion of the animal in the disinfectant solution.
- the present specification does not include wiping with cotton wool, gauze, a treatment sheet, or the like impregnated with cotton wool (swab method (cleaning method)).
- the "rubbing method (rubbing method)" (also called a waterless method) is a method of using a disinfectant solution and rubbing it on a disinfectant site (for example, fingers) until it dries.
- a disinfectant site for example, fingers
- the disinfectant solution can be sprayed on the palm, rubbed well on both hands, and then thoroughly drained with a non-woven fabric or a hand dryer and dried. The most effective and convenient.
- the "scrub method (cleaning method)" is a method in which a disinfectant solution containing a cleaning agent is used to whisk well and flush with running water. After hand washing, a paper towel or the like is used to completely wipe off the water. is there. A brush may be used. Dirt removal and disinfection can be done at the same time.
- the "basin method (immersion method)” is a method in which a sterilizing solution having a constant concentration is put into a basin (wash basin, etc.) and the sterilized part is immersed and washed. Soak a clean non-woven fabric or cloth in the disinfectant solution, soak the disinfectant part firmly, use the soaked non-woven fabric or cloth, wipe it in the liquid, and dry it thoroughly with a non-woven fabric or a hand dryer. Can be done by
- the "swab method (cleaning method)" is a method in which a disinfectant solution is sufficiently impregnated into absorbent cotton, gauze, non-woven fabric, etc., and the disinfectant site is wiped off.
- the swab method (cleaning method) is the least effective as compared with the other methods described above. In the present specification, the swab method (cleaning method) does not correspond to direct contact of the disinfectant solution with the animal.
- the "animal surface” refers to the surface of the animal body such as the skin, hair, claws, wings, scales, horns, and teeth of the animal. It also includes parts that can be easily contacted from the outside, such as the mouth.
- free chlorine is defined as "free residual chlorine and binding specified by the Minister of Health, Labor and Welfare based on the provisions of Article 17, Paragraph 2 of the Enforcement Regulations of the Waterworks Law. It is a value measured by Appendix 3 (hereinafter, colorimetric method (DPD indicator)) of "Chlorine Inspection Method”, and is a value obtained by oxidizing the DPD indicator.
- DPD indicator colorimetric method
- concentration of chlorite water indicates a value measured by the following (quantification method of chlorite water).
- high-level disinfectant (sterilizing solution) is classified by Spalding (Rutala WA: APIC Guideline for selection and use of disinfectants. 1996. Am J Infect Control 1996; 24: 3). It is one of the classifications of chemical disinfection methods. A disinfectant that kills all microorganisms, except when there are many spores. Glutaral preparations, phthalal preparations, peracetic acid preparations and the like can be mentioned.
- the term "medium-level disinfectant (disinfectant)” is classified by Spalding (Rutala WA: APIC Guideline for selection and use of disinfectants. 1996. Am J Infect Control 1996; 24: 3). It is one of the classifications of chemical disinfection methods. A disinfectant that kills tubercle bacilli, vegetative bacteria, most fungi, and most viruses, but not spores. Examples include sodium hypochlorite, povidone iodine preparations, and alcohols.
- the term "low-level disinfectant (disinfectant)” is classified by Spalding (Rutala WA: APIC Guideline for selection and use of disinfectants. 1996. Am J Infect Control 1996; 24: 3). It is one of the classifications of chemical disinfection methods. A disinfectant that kills most vegetative bacteria, certain fungi, and certain viruses. Examples include chlorhexidine preparations, quaternary ammonium salts, amphoteric surfactants and the like.
- halal correspondence does not include what is referred to as “haram (forbidden)” in Islamic teaching.
- Examples of “halal” include alcohol, animal components, and the like, and are shown in Halal hood guideline (Department of Halal Certification EU). In the present specification, it means that it is produced on a production line without containing “haram” such as alcohol, animal components, and fragrances from raw materials.
- a sterilizing solution containing chlorite water which sterilizes the animal by directly contacting the sterilizing solution with the animal. .. Since the disinfectant solution of the present disclosure comes into direct contact with animals, microorganisms such as filamentous fungi, bacteria, and viruses can be firmly removed, and it is unlikely that they will remain unremoved. The disinfectant solution of the present disclosure does not cause any damage even if it comes into direct contact with an animal because it is less irritating.
- the contact is achieved by a rubbing method (rubbing method), a scrub method (cleaning method) or a basin method (immersion method).
- rubbing method rubbing method
- scrub method cleaning method
- basin method immersion method
- higher sterilization effect can be obtained compared to the swab method (cleaning method).
- the level of direct contact with the skin is higher, so there are concerns about safety.
- the chlorinated water of the present disclosure is surprisingly used in the rubbing method, scrub method, basin method, etc. It was unexpectedly found that contacting the liquid directly with the animal did not cause damage to the skin such as fingers.
- the sterilizing solution containing a phosphoric acid buffer solution containing 0.5% to 20% of a 40,000 ppm chlorous acid water stock solution has a chlorous acid content of 200 ppm to 8000 ppm. If 1% of a 40,000 ppm chlorous acid water stock solution is blended, the amount of chlorous acid becomes 400 ppm. When 0.5% to 20% of a chlorous acid aqueous stock solution 4% to 6% (40,000 ppm to 60,000 ppm) product is blended, the amount of chlorous acid is 200 ppm to 12000 ppm.
- the phosphate buffer solution contains two or more types of phosphates.
- the phosphate buffer solution contains two or more of potassium dihydrogen phosphate, dipotassium hydrogen phosphate, and sodium dihydrogen phosphate.
- potassium dihydrogen phosphate is 0.68% to 13.61%
- sodium dihydrogen phosphate is 0.60% to 12.00%.
- Potassium dihydrogen phosphate is 0.7%, 0.8%, 0.9%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0. %, 7.0%, 8.0%, 9.0%, 10%, 11%, 12%, 13%, and can be any number between these values.
- Sodium dihydrogen phosphate is 0.60%, 0.7%, 0.8%, 0.9%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0. %, 6.0%, 7.0%, 8.0%, 9.0%, 10%, 11%, 12%, and can be any number between these values.
- potassium dihydrogen phosphate is 1% and sodium dihydrogen phosphate is 1%.
- potassium dihydrogen phosphate is 0.68% to 13.61%
- dipotassium hydrogen phosphate is 0.87% to 17.42%
- Potassium dihydrogen phosphate is 0.7%, 0.8%, 0.9%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0. %, 7.0%, 8.0%, 9.0%, 10%, 11%, 12%, 13%, and can be any number between these values.
- Dipotassium hydrogen phosphate is 0.9%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0. %, 9.0%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, and can be any number between these values.
- potassium dihydrogen phosphate is 1% and dipotassium hydrogen phosphate is 1%.
- the animal is a living animal.
- the animal includes the surface of the animal.
- the surface of the animal is skin.
- the surface of the animal is a finger.
- the animal includes the human body.
- the sterilization is performed in the preparation of food.
- Food preparation includes preparation in both food processing plants and cooking facilities (kitchens). Food preparation is done by those who are engaged in food processors and food handlers such as processed foods, those who cook and cook, those who use restaurants including restaurants and cooking facilities including kitchens, and those who go in and out of these places. It covers all people who do, raw material suppliers and distributors, those who serve food, those who directly touch food, those who indirectly touch food, and so on.
- Chlorous acid is about 10 ppm, about 15 ppm, about 20 ppm, about 25 ppm, about 30 ppm, about 40 ppm, about 50 ppm, about 60 ppm, about 70 ppm, about 80 ppm, about 90 ppm, about 100 ppm, about 150 ppm, about 200 ppm, about 250 ppm, About 300 ppm, about 350 ppm, about 400 ppm, about 450 ppm, about 500 ppm, about 550 ppm, about 600 ppm, about 650 ppm, about 700 ppm, about 750 ppm, about 800 ppm, about 850 ppm, about 900 ppm, about 950 ppm, about 1,000 ppm, about 1, 500ppm, about 2,000ppm, about 2,500ppm, about 3,000ppm, about 3,500ppm, about 4,000ppm, about 4,500ppm, about 5,000ppm, about 5,500ppm, about 6,000ppm, about 6,
- the free chlorine concentration of chlorinated water is about 0.25 mg / L, about 0.3 mg / L, about 0.35 mg / L, about 0.4 mg / L, about 0.45 mg / L, about 0.5 mg / L.
- the eradication targets at least one selected from viruses, bacteria, and eukaryotes.
- the eradication targets microorganisms that cause food poisoning, pathogenic microorganisms, microorganisms that may cause infectious diseases, drug-resistant bacteria (bacteria), and the like.
- the disinfectant solution does not contain animal-derived components, alcohol components, or fragrances.
- chlorous acid water 1.00%, sodium dihydrogen phosphate 1.00%, potassium dihydrogen phosphate 1.00% and ion-exchanged water 97.00 are halal-compatible hand sanitizers.
- This disinfectant solution does not contain animal-derived components, alcohol components, or fragrances, and is halal-compatible.
- the fingers can be easily sterilized by spraying directly onto the fingers without the need for dilution.
- a substance having high sterilizing power and sterilizing by directly contacting fingers has never existed and is the first in the world. It is said that a sterilizing solution containing such a concentration of phosphate buffer, chlorous acid, and free chlorine is safe for skin irritation, eye irritation, and skin sensitization while having high sterilizing power. The discovery is unpredictable.
- the sterilizing solution for halal-compatible fingers chlorous acid water 20.00%, potassium dihydrogen phosphate 1.00%, dipotassium hydrogen phosphate 1.00% and ion-exchanged water 78.00.
- This disinfectant solution does not contain animal-derived components, alcohol components, or fragrances, and is halal-compatible. It can be diluted (for example, 4-fold dilution, 8-fold dilution, 20-fold dilution) and used in processed food factories and mass cooking facilities, and can be used at low cost.
- the chlorite water used in the present disclosure has the characteristics found by the present inventors.
- a chlorite water produced by any method such as a known production method as described in the above-mentioned literature can be used.
- As a typical composition for example, 61.40% of chlorous acid water, 1.00% of potassium dihydrogen phosphate, 0.10% of potassium hydroxide and 37.50% of purified water are blended and used.
- 72% of chlorous acid water corresponds to 30,000 ppm of chlorous acid), but is not limited to this, and 0.25% to 75% of chlorous acid water and diphosphate.
- Potassium hydrogen may be 0.70% to 17.42%, and potassium hydroxide may be 0.10% to 5.60%.
- Sodium dihydrogen phosphate may be used instead of potassium dihydrogen phosphate, and sodium hydroxide may be used instead of potassium hydroxide.
- chlorite water 1.00% potassium dihydrogen phosphate, 1.00% sodium dihydrogen phosphate and 97.00% purified water are blended and used.
- chlorinated water is 0.1% to 5%
- potassium dihydrogen phosphate is 0.68% to 13.6%
- sodium dihydrogen phosphate is 0.60% to 12.0%. good.
- chlorite water As a typical composition, 20.00% chlorite water, 1.00% potassium dihydrogen phosphate, 1.00% dipotassium hydrogen phosphate and 78.00% purified water are blended and used. However, chlorite water is 15% to 25%, potassium dihydrogen phosphate is 0.68% to 13.6%, and dipotassium hydrogen phosphate is 0.87% to 17.4%. good.
- This agent reduces the decay of chlorous acid due to contact with organic matter under acidic conditions, but maintains its bactericidal effect.
- the generation of chlorine gas is slight, and it also has the feature of suppressing the amplification of the odor of a mixture of chlorine and organic substances.
- the chlorinated water of the present disclosure is reacted by adding sulfuric acid or an aqueous solution thereof in an amount and concentration capable of maintaining the pH value of the aqueous solution to 3.4 or less with an aqueous solution of sodium chlorate.
- This can be produced by generating chloric acid and then adding an amount of hydrogen peroxide equal to or greater than the amount required for the reduction reaction of the chloric acid.
- the chlorous acid water of the present disclosure is prepared by adding sulfuric acid or an aqueous solution thereof to an aqueous solution of sodium chlorate in an amount and concentration capable of maintaining the pH value of the aqueous solution at 3.4 or less.
- chloric acid is generated, and then chlorous acid is generated by adding an amount of hydrogen peroxide equal to or more than the amount required for the reduction reaction of the chloric acid. It is produced by adding either one of inorganic acids and inorganic acid salts alone, or two or more kinds of simple substances or a combination thereof, and adjusting the pH value within the range of 3.2 to 8.5. be able to.
- the chlorous acid water of the present disclosure is prepared by adding sulfuric acid or an aqueous solution thereof in an amount and concentration capable of maintaining the pH value of the aqueous solution to 3.4 or less in an aqueous solution of sodium chlorate.
- chloric acid is generated, and then chlorous acid is generated by adding an amount of hydrogen peroxide equal to or more than the amount required for the reduction reaction of the chloric acid.
- the pH value is adjusted within the range of 3.2 to 8.5 by adding any single substance of inorganic acid or inorganic acid salt or organic acid or organic acid salt, or two or more kinds of simple substances or a combination thereof. By doing so, it can be generated.
- the chlorinated water of the present disclosure is prepared by adding sulfuric acid or an aqueous solution thereof to an aqueous solution of sodium chlorate in an amount and concentration capable of maintaining the pH value of the aqueous solution at 3.4 or less.
- sulfuric acid or an aqueous solution thereof to an aqueous solution of sodium chlorate in an amount and concentration capable of maintaining the pH value of the aqueous solution at 3.4 or less.
- hydrogen peroxide in an amount equal to or greater than the amount required for the reduction reaction of the chloric acid to form an aqueous solution in which chloric acid is produced.
- Inorganic acid or inorganic acid salt alone or two or more types alone or a combination thereof and then either inorganic acid or inorganic acid salt or organic acid or organic acid salt alone or It can be produced by adding two or more kinds of simple substances or a combination thereof and adjusting the pH value within the range of 3.2 to 8.5.
- carbonic acid, phosphoric acid, boric acid or sulfuric acid can be used as the inorganic acid in the above method.
- the inorganic acid salt can be a carbonate, an inorganic hydroxide, a phosphate or a borate.
- sodium carbonate, potassium carbonate, sodium hydrogencarbonate or potassium hydrogencarbonate can be used as the carbonate.
- inorganic hydroxide sodium hydroxide or potassium hydroxide, calcium hydroxide, barium hydroxide can be used.
- the phosphate used is disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, tripotassium phosphate, dipotassium hydrogen phosphate or potassium dihydrogen phosphate. be able to.
- sodium borate or potassium borate can be used as the borate.
- the organic acid can be succinic acid, citric acid, malic acid, acetic acid or lactic acid.
- the organic acid salts include sodium succinate, potassium succinate, sodium citrate, potassium citrate, sodium malate, potassium malate, sodium acetate, potassium acetate, sodium lactate, potassium lactate.
- calcium lactate can be used.
- chlorous acid water containing chlorous acid (HClO 2 ) that can be used as a bacterial killing agent
- sulfuric acid (H 2 SO 4 ) or an aqueous solution thereof is added to an aqueous solution of sodium chlorate (NaClO 3 ).
- chlorous acid (HClO 3 ) obtained under acidic conditions is added with hydrogen peroxide (H 2 O 2 ) in an amount necessary for converting chloric acid (HClO 3 ) into chlorous acid by a reduction reaction. (HClO 2 ) is produced.
- the basic chemical reaction of this production method is represented by the following formulas A and B.
- Formula A shows that chloric acid can be obtained by adding sulfuric acid (H 2 SO 4 ) or an aqueous solution thereof in an amount and concentration that can maintain the pH value of an aqueous solution of sodium chlorate (NaClO 3 ) within acidic conditions. Then, the B-type, chlorate (HClO 3) is reduced with hydrogen peroxide (H 2 O 2), shows that the chlorite (HClO 2) is generated.
- chlorine dioxide gas (ClO 2 ) is generated (C type), but by coexisting with hydrogen peroxide (H 2 O 2 ), chlorous acid (HClO 2) undergoes the reactions of formulas D to F. ) Is generated.
- chlorous acid HClO 2
- chloride ion Cl ⁇
- hypochlorous acid HClO
- chlorous acid (HClO 2 ) or chlorine dioxide gas (ClO 2 ) obtained by the above method, or an aqueous solution containing these contains either a single inorganic acid, an inorganic acid salt, an organic acid or an organic acid salt, or two types.
- Chlorous acid (HClO 2 ) can be stably maintained for a long period of time by creating a transition state and delaying the decomposition reaction by adding the above single substance or a combination thereof.
- chlorous acid (HClO 2 ) or chlorine dioxide gas (ClO 2 ) obtained by the above method or an aqueous solution containing these is mixed with an inorganic acid or an inorganic acid salt, specifically, a carbonate or an inorganic hydroxide. It is possible to use a single substance, two or more types of single substances, or a combination of these.
- an inorganic acid or an inorganic acid salt specifically, an inorganic acid or an inorganic acid salt, or an aqueous solution obtained by adding a carbonate or an inorganic hydroxide as a simple substance or two or more kinds of simple substances or a combination thereof. It is possible to use an organic acid or an organic acid salt added alone, two or more kinds alone, or in combination thereof.
- an inorganic acid, an inorganic acid salt, an organic acid or an organic acid salt is added to the aqueous solution produced by the above method alone, in combination of two or more kinds, or in combination thereof. You can use things.
- Examples of the above-mentioned inorganic acid include carbonic acid, phosphoric acid, boric acid and sulfuric acid.
- Examples of the inorganic salt include carbonates and inorganic hydroxides, as well as phosphates and borates. More specifically, the carbonates include sodium carbonate, potassium carbonate and sodium hydrogen carbonate.
- Potassium hydrogen carbonate, inorganic hydroxides are sodium hydroxide and potassium hydroxide, calcium hydroxide, barium hydroxide, phosphates are disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, phosphate.
- tripotassium, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, and borate sodium borate and potassium borate may be used.
- organic acid examples include succinic acid, citric acid, malic acid, acetic acid and lactic acid.
- organic acid salt sodium succinate, potassium succinate, sodium citrate, potassium citrate, sodium malate, potassium malate, sodium acetate, potassium acetate, sodium lactate, potassium lactate or calcium lactate are suitable.
- the decomposition rate of the chlorite aqueous solution at pH increases as the pH decreases, that is, the acid becomes stronger. That is, the absolute speeds of the reactions (a), (b) and (c) in the above formula are increased.
- the proportion of the reaction (a) decreases as the pH decreases, but the total decomposition rate fluctuates greatly, that is, increases, so that the amount of chlorine dioxide (ClO 2 ) generated also increases as the pH decreases.
- the lower the pH value the faster the sterilization and bleaching, but the irritating and harmful chlorine dioxide gas (ClO 2 ) makes the work difficult and adversely affects human health.
- the reaction of chlorous acid to chlorine dioxide proceeds rapidly, the chlorous acid becomes unstable, and the time during which the bactericidal activity can be maintained is extremely short.
- the pH is determined from the viewpoint of suppressing the generation of chlorine dioxide and balancing with the bactericidal activity. Adjust the value within the range of 3.2 to 8.5.
- the sterilizing solution of the present disclosure can sterilize an animal by directly contacting the animal.
- a sterilization method a rubbing method (rubbing method), a scrub method (cleaning method), or a basin method (immersion method) can be used.
- the swab method cleaning method may be used. In food processing plants, restaurants including cafeterias, cooking facilities including kitchens, etc., sterilization can be performed at the time of admission, and sterilization can be performed each time.
- chlorous acid aqueous preparation used in the following examples was produced as follows.
- chlorinated water may be abbreviated as "sub-water”, but it has the same meaning.
- chlorinated water preparation was manufactured based on the following formulation.
- the concentration of "chlorite water” was measured based on the above “quantification method of chlorite water” for the “chlorite water preparation produced with chlorite water” prepared based on the above preparation method, and each implementation was carried out.
- the chlorinated water of each example was prepared using a buffer solution (a phosphate buffer solution containing dipotassium hydrogen phosphate and potassium dihydrogen phosphate) prepared to have the free chlorine concentration described in the examples. ..
- the contact time was 5 minutes.
- a sterilizing effect of 3 Logs or more was observed from the first time, and the sterilizing effect of 3 Logs or more was maintained until the 10th time.
- the contact time was 2 minutes, the sterilization effect of 2 Log or more, which was the standard value, was not observed at the first time.
- hypochlorous acid aqueous preparation was evaluated by ASTEM Standard E1174 at two set values (free chlorine concentration 25 mg / L, content of HClO 2 of 1,000 ppm; and free chlorine concentration of 10 mg / L, content of HClO 2 of 400 ppm). It is shown that it meets the criteria based on the criteria and has a sufficient sterilizing effect.
- the sterilization effect was confirmed by the rubbing method (waterless method), which is one of the hand disinfection (sterilization) methods during surgery in hospitals.
- the method of using the hand disinfectant (sterilization) agent installed at the entrance or the entrance / exit of the facility is as follows (the amount of one discharge of the dispenser is 3 ml / one time). Used in. (See “How to use hand sanitizer (sterilization) medicine" (see https://www.yoshida-homecare.com/jitsurei/01.html)
- Example 2 Skin irritation test of chlorite water preparation using rabbit
- a skin irritation test was conducted using 3 female Kbl: NZW rabbits.
- three animals treated with sodium hypochlorite were set as control groups, and their irritant responses were compared.
- 0.5 mL of the test substance was evenly applied to a lint cloth patch, which was exposed to the back skin of the rabbit for 4 hours. Skin reactions and general conditions were observed daily for 1, 24, 48 and 72 hours and up to 14 days after patch removal.
- body weight was measured before administration and at the end of observation.
- the GHS hazard category skin corrosive and skin irritant
- the GHS hazard category skin corrosive and skin irritant
- Test materials and methods 14.1. Test animal 14.1.1. Rabbit Seed 14.1.2. System [Grade] New Zealand White Species (Kbl: NZW) [SPF] 14.1.3. Producer Kitayama Labes Co., Ltd. 14.1.4. Where to buy Oriental Yeast Co., Ltd. 14.1.5. Reasons for selecting the test system For animals, the white rabbit recommended by the guidelines was selected. For the strain, the New Zealand white rabbit, which is widely used for this type of test, was selected. 14.1.6. Weekly age A 16-week-old animal was purchased and the test substance was administered at 17-week-old (body weight range: 2.89 to 3.20 kg). 14.1.7. Number of animals purchased 7 females 14.1.8. Number of animals used 6 females
- Breeding management 14.2.1. Breeding environment Animals were bred in the 7-207 breeding room [positive pressure] (W4.8 x D 10.3 x H 2.6 m), and the standard values for environmental control were as follows. Temperature: 17-23 ° C (measured value: 20.8-21.4 ° C) Humidity: 35-70% RH (measured value: 50-67% RH) Ventilation rate: 8 times or more / h Lighting: 12 hours (lit at 7 o'clock, turned off at 19:00) One animal was housed in a breeding cage (W62.2 x D 75.6 x H 46.2 cm). The breeding cage was changed every other week and the feeder was changed once a week. 14.2.2. Feed Solid feed (RC4, LotNo.
- the quarantine period was from the delivery of animals to the weight measurement on the day before administration, and the acclimation period was before administration. During this period, the general condition was observed once a day (excluding Saturday and Sunday), and the body weight was measured at the time of delivery and the day before administration (before hair cutting).
- Individual identification Kitayama Labes Co., Ltd. uses the serial number entered on the auricle of the animal as the animal number (Animal ID No.), and attaches the animal identification card (Animal ID card) that specifies the animal number to the cage. Was identified.
- Test group composition and reasons for choosing test method 14.7.1.
- Reasons for selecting the test method Based on the information that chlorinated water is not irritating to the skin, a method of exposing the test substance to a total of 3 rabbits for 4 hours was selected according to the test guidelines. Even in the sodium hypochlorite preparation, there was no description indicating corrosiveness from the product package insert.
- test substance was used as it was for administration.
- test substances and comparative control substances were classified into the GHS [2] hazard category. If it is not classified into categories 1 to 3, it is excluded from the category.
- Comparative control substance treatment group (Table 1-2) The average score of erythema / scab and edema of each animal at 48, 72 hours and 4 days after patch removal, which maximizes the total skin reaction score, was calculated and found to be 3.0 for erythema / scab and 3.0 for edema. It was 2.7 to 3.0.
- GHS hazard category corrosive and irritating to the skin
- the skin (irritating) reaction of all cases did not recover during the observation period, and up to 14 days after patch removal, which was judged to be a corrosive reaction in one case. Since scars that did not heal were observed, it was classified as Category 1 (corrosive).
- the GHS hazard category skin corrosive and skin irritant
- the GHS hazard category skin corrosive and skin irritant
- Example 3 Eye irritation test of chlorite water preparation using rabbit
- an eye irritation test was conducted using 3 female Kbl: NZW rabbits.
- 0.1 mL of the test substance was administered into the conjunctival sac of the animal's right eye.
- Ocular reactions in the treated eyes were observed 1, 24, 48 and 72 hours after administration and the general condition was observed, and body weight was measured before and at the end of observation.
- the condition of the corneal epithelium Presence or absence of damaged site was confirmed by staining with an aqueous solution of sodium fluorescein.
- Test substance 13.1. Name Japanese name: Chlorous acid water (formulation) English name: Chlorous acid water (formulation)
- Test materials and methods 14.1. Test animal 14.1.1. Rabbit Seed 14.1.2. System [Grade] New Zealand White Species (Kbl: NZW) [SPF] 14.1.3. Producer Kitayama Labes Co., Ltd. 14.1.4. Where to buy Oriental Yeast Co., Ltd. 14.1.5. Reasons for selecting the test system For animals, the white rabbit recommended by the guidelines was selected. For the strain, the New Zealand white rabbit, which is widely used for this type of test, was selected. 14.1.6. Weekly age A 10-week-old animal was purchased and the test substance was administered at 11-week-old age (body weight range: 2.10 to 2.30 kg). 14.1.7. Number of animals purchased 4 females 14.1.8. Number of animals used 3 females
- the quarantine period was from the delivery of animals to the weight measurement on the day before administration, and the acclimation period was before administration. During this period, the general condition was observed once a day (excluding Saturday and Sunday), and the body weight was measured at the time of delivery and the day before administration (before confirmation of corneal epithelium).
- Test group composition and reasons for choosing test method 14.7.1.
- test substance was used as it was for administration.
- Observation, measurement and inspection 15.1. Observation of ocular response Responses in the cornea, iris and conjunctiva of the eye administered 1, 24, 48 and 72 hours after administration were observed and scored according to the criteria for ocular response (Draize [1], 1959). Regarding the state of the corneal epithelium, 24 hours after administration, a 2% aqueous solution of sodium fluorescein was instilled, washed with physiological saline, and then the stained (damaged) range of the cornea was observed. In addition, as reference data, the treated eyes of all the cases were photographed using a digital camera during observation 24 hours after the administration.
- Conjunctiva A Conjunctival redness (eyelid conjunctiva and eyeball conjunctiva excluding cornea and iris) Blood vessels are normal ⁇ 0 Blood vessels are clearly hyperemic than normal ⁇ 1 Diffuse, crimson and difficult to distinguish individual blood vessels ⁇ 2 Diffuse beef-like red ⁇ 3
- a Maximization Test was conducted using 20 Slc: Hartley female guinea pigs (SPFs) in order to obtain information on the skin sensitization of chlorinated water preparations.
- the medium and treatment concentration in the skin sensitization test were set based on the results of the preliminary test conducted in advance.
- 10 animals were used to inject 0.2 w / v% test substance solution (medium: distilled water) intradermally in the first sensitization treatment, and 100% test substance solution in the second sensitization treatment. (Undiluted solution) was closed and pasted for 48 hours.
- a 20 w / v% test substance solution was occluded and applied for 24 hours.
- control groups 5 negative control groups using a medium during intradermal sensitization treatment and 5 positive control groups using the positive control substance ⁇ -Hexyl cinnamaldehyde (HCA) were provided. Skin reactions were observed at all evoked treatment sites in each group.
- HCA ⁇ -Hexyl cinnamaldehyde
- the skin sensitization rate of the test substance was calculated to be 0%, and since it did not reach the lower limit of any of the GHS hazard categories (skin sensitization), it was judged to be out of the category.
- a skin reaction with a score of 3 was observed in all 5 cases in the positive control group, and no animal showed a skin reaction in the negative control group.
- the skin sensitization rate of the positive control substance was calculated to be 100%, and the skin sensitization of HCA, which is the positive control substance, was confirmed. Therefore, the skin sensitization of the chlorous acid water preparation was appropriately evaluated in the test. It was judged that it was done.
- HCA Positive control substance
- ⁇ -Hexyl cinnamaldehyde which is widely used in sensitization tests and is exemplified in the guideline, was selected as the positive control substance.
- Test materials and methods 14.1.
- Reasons for selecting the test system The guinea pigs recommended in the test guidelines were selected. For the strain, the Slc: Hartley strain was selected in consideration of susceptibility to known chemical substances, genetic stability, and the like. 14.1.5. Weekly age A 6-week-old animal was purchased and started at 7-week-old (body weight range: 384-452 g). 14.1.6. Number of animals purchased 22 females 14.1.7. Number of animals used 20 females
- Breeding management 14.2.1. Breeding environment Animals were bred in the 7-201 breeding room [positive pressure] (W6.4 x D 10.3 x H 2.6 m), and the standard values for environmental control were as follows. Temperature: 20-26 ° C (measured value: 22.8-23.3 ° C) Humidity: 35-70% RH (measured value: 48-61% RH) Ventilation rate: 12 times or more / h Lighting: 12 hours (lit at 7 o'clock, turned off at 19:00) Using a flush-type breeding machine (Toyo Riko), one animal was housed in an aluminum front and floor stainless steel mesh breeding cage (W 29.1 x D 26.3 x H 18.0 cm).
- a water quality inspection based on the Water Supply Law was conducted by an external organization in April 2017, and it was confirmed that the inspection results were within the standard values of the water supply quality standard (Report No. K17-0031).
- a bacterial test (general bacterial and E. coli test) was conducted at the reputation center in June, July and August 2017, and it was confirmed that no bacteria were detected (GT17-06). , GT17-07, GT17-08).
- the period from the delivery of animals to the start of sensitization treatment was defined as the quarantine and habituation period.
- the quarantine and habituation period The period from the delivery of animals to the start of sensitization treatment was defined as the quarantine and habituation period.
- the general condition of the animals was observed once daily (excluding Saturdays and Sundays) and acclimatized to the test environment.
- body weight was measured at the time of delivery and before the start of sensitization treatment (at the end of the quarantine / acclimation period). No abnormalities were found in any of the animals in these observations and measurements.
- Grouping Grouping was performed on Day 0 (sensitization treatment start date).
- test group composition Composition of test group and reason for setting concentration 14.7.1.
- Test group composition FCA: Freund's complete adjuvant -: Only the patch was treated. 14.7.2.
- Reason for setting the concentration The treatment concentration of the test substance was set based on the results of the preliminary test [Test No. H520 (697-003)] (GLP not applied). In the preliminary test, a total of 9 concentrations of test substance solution of 0.1, 0.2, 0.5, 1, 2, 5, 10, 20 and 50 w / v% (medium: distilled water) were applied to each animal at two locations of 0.1 mL each.
- a corrosive reaction (white spots or crusting at the administration site) was observed at the administration site at a concentration of 0.5 w / v% or more 24 hours after the administration.
- a skin reaction with a score of 2 was observed at the 0.2 w / v% administration site and a score of 1 or 2 was observed at the 0.1 w / v% administration site.
- a total of 3 concentrations of 4, 20 w / v% (medium: distilled water) and 100% (stock solution) of the test substance were occluded and applied to 2 animals for 24 hours, and as a result, 100% was applied 24 hours after patch removal.
- a moderate skin reaction was observed at the application site of 20 w / v% or less, and no skin reaction was observed at the application site of 20 w / v% or less. No abnormalities in general condition were observed in animals with intradermal injection and occlusion application.
- the intradermal injection of the sensitization treatment in this test gave a moderate (score 2) skin reaction, and the highest concentration of 0.2 w / v%, which did not show a corrosive reaction, was felt.
- Test substance treatment group (100% test substance solution) A stock solution of the test substance was used. 14.9.3.2. Negative control group No administration solution was used. 14.9.3.3. Positive control group (100% HCA solution) The HCA stock solution was used.
- test substance treatment group and negative control group (20w / v% test substance solution) 2 g of test substance was weighed. Distilled water (water for injection, LotNo. K6D73) was added thereto, and the mixture was stirred and the volume was adjusted to 10 mL. 14.9.4.2. Positive control group and negative control group (10w / v% HCA solution) HCA 0.3g was weighed. Liquid paraffin (Lot No. 816186, Yoshida Pharmaceutical Co., Ltd.) was added thereto, and the mixture was stirred and the volume was adjusted to 3 mL.
- Sensitization treatment 1st (Day0) Hair was removed from the back of the chest of the animal using an electric clipper and a shaver. A 2 x 4 cm administration section (image 1, the area surrounded by (1) to (3)) was provided on the hair removal site by marking with an oil-based pen. 0.1 mL of each of the prepared administration solutions (1) to (3) (section 14.9.1.) of each test group was intradermally injected so as to correspond to the administration sites (1) to (3) of Image 1. 14.10.2. Open application of 10% sodium dodecyl sulfate mixture (Day7) On Day 7, the back of the chest of the animal (the part of images 1 and (4)) was depilated using an electric clipper and a shaver.
- a 10% sodium dodecyl sulfate mixture (Section 14.9.2.) was thinly and uniformly openly applied to the same site in the test substance treatment group and the negative control group. 14.10.3.
- Second sensitization procedure (Day 8-10) A 2 x 4 cm filter paper coated with surgical tape (2 inches wide, Blenderm TM , 3M) on one side, using a pipette (MICROMAN®, model M1000, Gilson) to administer each test group (14.9. 3.) 0.2 mL was applied evenly. This patch was applied to the administration compartments (sites in images 1 and 4) to correspond to the administration site in each test group and then secured with surgical tape (2 inches wide, Transpore TM , 3M).
- This patch was applied to the administration compartments (sites in images 1, (5) and (6)) so as to correspond to the administration site in each test group, and then fixed with surgical tape (width 2 inches, Transpore TM , 3M). After applying the occlusion for 24 hours, the patch was removed and the site to be treated was marked with an oil-based pen. The test substance remaining at the site of induction treatment was removed using distilled water and tissue paper.
- the skin sensitization rate was calculated as [(number of sensitization-positive animals / number of animals used) x 100].
- the occurrence of skin reaction at the site of induction treatment was confirmed (skin sensitization rate of 30% or more), and it was confirmed that the experimental method was appropriate.
- Test results 17.1. Observation of skin reaction (Appendix1, Photographs 1 to 4 (Figs. 4 to 7)) Observation of the site of evoked treatment treated with the test substance showed no skin reaction in any of the animals. On the other hand, when observing the site of induction treatment of the positive control substance, a skin reaction with a score of 3 was observed in all 5 cases in the positive control group, and no animal showed a skin reaction in the negative control group.
- Weight measurement (Appendix2) Body weight at the end of observation of all animals increased from the start of sensitization (Day 0).
- the disinfectant solution containing chlorite water is "out of classification" in terms of skin corrosiveness and irritation, serious damage to the eyes or eye irritation, and skin sensitization. That is, when a disinfectant solution containing chlorite water is applied to the skin, there is no corrosive reaction on the skin, there is no erythema or edema, and when applied to the eye, the cornea, glow, and conjunctiva are normal. It has been shown to show no skin sensitization.
- sodium hypochlorite is "Category 1" in terms of skin corrosiveness and irritation, as well as severe damage or eye irritation to the eye, and is very mild when applied to the skin.
- Ethanol is "Category 2B” or “Category 2" for severe eye damage or irritation to the eye, and a positive reaction above a certain score in corneal opacity, ulceris, uveitis, and / or chemosis.
- disinfectants containing chlorinated water do not cause harmful events when in direct contact with animals and can directly disinfect animals.
- the sterilizing solution containing chlorinated water has high sterilizing performance and can come into direct contact with animals, so the rubbing method (rubbing method), scrub method (cleaning method), and basin method (immersion method) It has been shown that sterilization can be performed firmly by using a disinfection method with a high sterilization effect.
- the disinfectant solution of the present disclosure can be used for disinfecting animals.
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2019
- 2019-08-08 JP JP2021537544A patent/JPWO2021024485A1/ja active Pending
- 2019-08-08 EP EP19940811.3A patent/EP4014980A4/de active Pending
- 2019-08-08 US US17/633,722 patent/US20220331467A1/en active Pending
- 2019-08-08 WO PCT/JP2019/031501 patent/WO2021024485A1/ja unknown
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Also Published As
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JPWO2021024485A1 (de) | 2021-02-11 |
JP2024091855A (ja) | 2024-07-05 |
EP4014980A1 (de) | 2022-06-22 |
US20220331467A1 (en) | 2022-10-20 |
EP4014980A4 (de) | 2023-05-10 |
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